A Health Affairs article published this past January described the current system’s complexity. More than 20,000 prescription drugs and more than 13,000 facilities worldwide are registered to make drugs or their active ingredients. More than three-quarters of active pharmaceutical ingredients are made outside the United States, the authors said.
Experts acknowledge that relying on overseas drug manufacturers can lead to quality control and oversight problems, because it’s harder for the FDA to inspect plants overseas. For example, after an FDA inspection last December that found numerous manufacturing problems, Intas Pharmaceuticals in India voluntarily suspended production and distribution of its products that were destined for the United States. The company was allowed to distribute some drugs, including critical cancer drugs, that are in short supply, with strict third-party oversight. In the video, Trump also zeroed in on this concern. He pledged — with an emphasis on minimizing China’s role in the production of medications — to return manufacturing of all essential medicines to the United States, “where they belong.”
But the United States experiences manufacturing problems and weather emergencies, just as everywhere else in the world does. For example, Lake Forest, Illinois-based drugmaker Akorn filed for bankruptcy this year and stopped making more than 70 generic drugs. After a tornado hit its Rocky Mount, North Carolina, plant in July, Pfizer temporarily shuttered the facility. The company said Sept. 25 that it had restarted production at the plant.
“Bringing all manufacturing back to the United States not only isn’t feasible, because we don’t have the raw materials, but that also creates a reliance on a single geographical area,” said Soumi Saha, senior vice president of government affairs at Premier, a large group-purchasing organization for hospitals and other health providers. “What you need is global diversification.”